End errector for use with a flexible endoscopic surgical instrument for invagination and fundoplication

ABSTRACT

An endoscopic surgical instrument includes a flexible tube, a grasping and fastening end effector coupled to the distal end of the tube, and a manual actuator coupled to the proximal end of the tube. The manual actuator is coupled to the end effector by a plurality of flexible cables which extend through the tube. The tube contains a lumen for receiving a manipulable endoscope and the end effector includes a passage for the distal end of the endoscope. The end effector has a store for a plurality of male fastener parts, a store for a plurality of female fastener parts, a rotatable grasper, a rotatable fastener head for aligning a female fastener part and a male fastener part with tissues therebetween, and a firing member for pressing a male fastener part through tissues grasped by the grasper and into a female fastener part. According to a presently preferred embodiment the overall diameters of the flexible tube and the end effector (when rotated to the open position) do not exceed approximately 20 mm so that the instrument may be delivered transorally to the fundus of the stomach. The manual actuator is provides with a lock-out feature which prevents firing male fastener parts before the fastener head is closed. The instrument is advantageously utilized in a fundoplication procedure.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The invention relates to an endoscopic surgical instrument. Moreparticularly, the invention relates to a flexible instrument for thetransoral invagination and fundoplication of the stomach to theesophagus.

[0003] 2. State of the Art

[0004] Gastroesophageal fundoplication is a procedure for the treatmentof gastroesophageal reflux disease (GERD), a condition in which gastricacids are regurgitated into the esophagus resulting in esophagitis,intractable vomiting, asthma, and aspiration pneumonia. Thefundoplication procedure involves wrapping the fundus of the stomacharound the lower end of the esophagus and fastening it in place.Traditionally, this procedure is accomplished via open surgery with theuse of sutures to secure the plicated fundus of the stomach around theesophagus without penetrating (incising) the stomach.

[0005] U.S. Pat. No. 5,403,326 to Harrison et al. discloses a method ofperforming endoscopic fundoplication using surgical staples or two-partsurgical fasteners. The procedure disclosed by Harrison et al. involvesperforming two percutaneous endoscopic gastrotomies (incisions throughthe skin into the stomach) and the installation of two ports throughwhich a stapler, an endoscope, and an esophageal manipulator(invagination device) are inserted. Under view of the endoscope, theesophageal manipulator is used to pull the interior of the esophagusinto the stomach. When the esophagus is in position, with the fundus ofthe stomach plicated, the stapler is moved into position around thelower end of the esophagus and the plicated fundus is stapled to theesophagus. The process is repeated at different axial and rotarypositions until the desired fundoplication is achieved. While, theprocedure disclosed by Harrison et al. is a vast improvement over opensurgery, it is still relatively invasive requiring two incisions throughthe stomach. Moreover, the procedure requires the manipulation of twodifferent tools in order to position the fundus and to secure the fundusto the esophagus.

[0006] U.S. Pat. No. 5,571,116 to Bolanos et al. discloses anon-invasive treatment of gastroesophageal reflux disease which utilizesa remotely operable invagination device and a remotely operable surgicalstapler, both of which are inserted transorally through the esophagus.According to the methods disclosed by Bolanos et al., the invaginationdevice is inserted first and is used to clamp the gastroesophagealjunction. The device is then moved distally, pulling the clampedgastroesophageal junction into the stomach, thereby invaginating thejunction and involuting the surrounding fundic wall. The stapler is theninserted transorally and delivered to the invaginated junction where itis used to staple the fundic wall.

[0007] Bolanos et al. disclose several different invagination devicesand several different staplers. Generally, each of the staplersdisclosed by Bolanos et al. has an elongate body and a spring biasedanvil which is rotatable approximately 15° away from the body in orderto locate the invaginated gastroesophageal junction between the body andthe anvil. The body contains a staple cartridge holding a plurality ofstaples, and a staple firing knife. Each of the invagination devicesdisclosed by Bolanos et al. has a jaw member which is rotatable at least45° and in some cases more than 90° to an open position for grasping thegastroesophageal junction. One of the chief disadvantages of the methodsand apparatus disclosed by Bolanos et al. is that the stapler and theinvagination device must be both be present in the esophagus at the sametime. With some of the embodiments disclosed, the presence of bothinstruments is significantly challenged by the size of the esophagus. Inall of the embodiments, the invagination device is always laterallyspaced apart from the stapler. Thus, the stapler cannot staple theinvaginated tissue, per se, but can only staple tissue which islaterally adjacent to the invaginated tissue. The relatively smallrotational movement of the anvil of the stapler further complicates theaccommodation of tissue adjacent to the invaginated tissue. In addition,surgical staples have some inherent disadvantages as compared to otherfasteners. The relatively small surface area of surgical staples allowsthem to pass through tissue over time, thereby unfastening the tissueand allowing the staples to migrate to other parts of the body. Bolanoset al. appears to recognize this disadvantage and proposes theapplication of a bolster or pledger to the tissues prior to stapling.Bolanos et al. do not explain how this can be accomplished transorallyusing the apparatus disclosed. In addition, while Bolanos et al. make abroad reference to other types of fasteners, the substantial sizeconstraints imposed on the apparatus which are delivered transorallywould seem to prohibit any type of fastener other than the staples shownby Bolanos et al. The actuating mechanism of the device disclosed byBolanos et al. is somewhat awkward. In particular, the stapler anvil isbiased to the open position, and it is not clear whether or not thestapler anvil can be locked in a closed position without continuouslyholding down a lever. In addition, it appears that the staple firingtrigger can be inadvertently operated before the anvil is in the closedposition. This would result in inadvertent ejection of staples into thestomach or the esophagus of the patient.

SUMMARY OF THE INVENTION

[0008] It is therefore an object of the invention to provide anendoscopic surgical instrument for invagination and fundoplication ofthe stomach to the esophagus.

[0009] It is also an object of the invention to provide an endoscopicsurgical instrument for invagination and fundoplication of the stomachto the esophagus which is minimally invasive.

[0010] It is another object of the invention to provide an endoscopicsurgical instrument for invagination and fundoplication of the stomachto the esophagus utilizing fasteners which do not require bolsters orpledgers.

[0011] It is a further object of the invention to provide an endoscopicsurgical instrument for invagination and fundoplication of the stomachto the esophagus which is delivered transorally to the surgical site.

[0012] It is an additional object of the invention to provide anendoscopic surgical instrument for invagination and fundoplication ofthe stomach to the esophagus which is capable of plicating tissuedirectly in line with invaginated tissue.

[0013] Yet another object of the invention is to provide an endoscopicsurgical instrument for invagination and fundoplication of the stomachto the esophagus which is easy to use and which cannot be accidentallytriggered.

[0014] In accord with these objects which will be discussed in detailbelow, the endoscopic surgical instrument of the present inventionincludes a torsionally rigid but flexible tube having a proximal end anda distal end, a grasping and fastening end effector coupled to thedistal end of the tube, and a manual actuator coupled to the proximalend of the tube. The grasping and fastening end effector preferablyincludes a separate grasper and a separate fastener. The manual actuatoris coupled to the grasper and fastener of the end effector by aplurality of flexible cables which extend through the flexible tube. Thetube preferably contains a lumen for receiving a manipulable endoscopeand the end effector preferably includes a passage for the distal end ofthe endoscope. The end effector has a store for a plurality of malefastener parts, a store for a plurality of female fastener parts, arotatable fastener head for aligning a male fastener part and a femalefastener part with tissues therebetween, a rotatable firing member forpressing a male fastener part through the tissues and into a femalefastener part, and a rotatable grasper located between the fastener headand the firing member.

[0015] According to presently preferred embodiments, the overalldiameters of the flexible tube and the end effector (when the fastenerhead is rotated to the open position and the grasper is rotated to theclosed position) do not exceed approximately 20 mm (and preferably lessthan 16 mm) so that the instrument may be delivered transorally to thefundus of the stomach. The end effector preferably includes asubstantially cylindrical stationary part which houses the store of malefastener parts and the firing member. Male fastener parts are ejected bythe firing member through a substantially radial port in thesubstantially cylindrical stationary part of the end effector. Therotatable fastener head is hingedly coupled to a distal portion of thestationary part of the end effector and is rotatable from a first (open)position wherein the fastener head is rotated distally away from thestationary part to a second (closed) position wherein the fastener headis rotated proximally toward the stationary part. The store of femalefastener parts is preferably contained within the fastener head and afemale fastener shuttle on the fastener head moves a female fastenerfrom the store into alignment with the substantially radial port whenthe fastener head is rotated to the closed position.

[0016] The presently preferred store for male fastener parts includes alongitudinal track arranged proximally of the rotatable firing member inwhich male fastener parts are arranged one behind the other. Malefastener parts are moved distally along the track by a first biasingmember. According to one embodiment, the firing member includes a flangewhich blocks distal movement of male fastener parts while a malefastener part is being ejected. According to a presently preferredembodiment, a spring leaf with a pair of bent teeth engages the distalend of the next male fastener part in the track keeping it from movingoff the track. When the firing member moves down to grab another malefastener part, the leaf is deflected allowing the next male fastenerpart to enter the firing member. The presently preferred store forfemale fastener parts includes an orthogonal chamber in which femalefastener parts are stacked on top of each other and a second biasingmember for moving the female fastener parts onto the female fastenershuttle. The presently preferred female fastener shuttle is a slidingtray which is located adjacent to the store of female fastener parts.The second biasing member pushes female fastener parts into the tray andthe tray moves laterally away from the store of female fastener partswhen the rotatable fastener head is moved from the open position to theclosed position.

[0017] The rotatable fastener head, the firing member, and the grasperare preferably each controlled by an individual cable; and the proximalactuator includes three levers, each coupled to a respective cable, forindividually operating the rotatable fastener head, the firing member,and the grasper. According to a presently preferred embodiment, themanual actuator includes a lock-out feature which prevents theinadvertent firing of male fastener members until the fastener head isrotated into the proper position. The manual actuator also includes areleasable lock for locking the grasper in the closed position.

[0018] According to one embodiment, the male fastener member is acircular disk with a central upstanding barbed projection and the femalefastener member is a circular disk with a central hole engageable by thebarbed projection of a male fastener member. According to another,presently preferred embodiment, the female fastener is rectangular witha central hole engageable by the barbed projection of a male fastenermember. The female member is preferably provided with a plurality ofweak peripheral extensions which allow the member to be held in theshuttle tray, but forcibly removed therefrom after it is coupled to amale member.

[0019] The apparatus of the invention is advantageously utilized in afundoplication procedure. The instrument is prepared by inserting amanipulable endoscope into the proximal end of the instrument andthreading the endoscope through the lumen of the flexible tube outthrough the end of the end effector. With the grasper closed and therotatable fastener head in the first (open) position, the end effectoris inserted into the mouth of the patient and guided down through theesophagus into the stomach with the aid of the endoscope. When the endeffector is distal of the fundus (or lower esophageal sphincter), thegrasper is opened and the end effector is raised toward the fundus sothat the fundus and the lower end of the esophagus are located betweenthe stationary part of the end effector and the grasper. The grasper isthen closed to clamp together the tissue around the juncture of theesophagus and the fundus. With the grasper closed, the rotatablefastener head is closed, raising it up toward the fundus and lifting thefundus up against the esophagus. With the instrument in thisconfiguration, the firing member is actuated and a male fastener memberis ejected out of the radial port, through the esophagus and the fundus,and into a female fastener member which is held by the tray in therotatable fastener head. The firing member is then returned to itsinitial position moving the flange or the leaf away from the malefastener store and allowing a second male fastener to be pushed onto thesecond rotatable member. The rotatable fastener head is moved to theopen position, releasing the female fastener, and returning the tray tothe store of female fasteners to receive a second female fastener. Thegrasper is opened and the instrument may then be repositioned and theabove procedure repeated until the desired fundoplication is achieved.

[0020] Additional objects and advantages of the invention will becomeapparent to those skilled in the art upon reference to the detaileddescription taken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021]FIG. 1 is an enlarged broken perspective view of a firstembodiment of a flexible endoscopic surgical instrument according to theinvention with the end effector in a fully open position;

[0022]FIG. 2 is an enlarged broken perspective view of the distal end ofthe instrument of FIG. 1 with the grasper of the end effector in aclosed position;

[0023]FIG. 3 is an enlarged broken perspective view of the distal end ofthe instrument of FIG. 1 with the end effector in a fully closedposition;

[0024]FIG. 4 is an enlarged proximal end view of the end effectorremoved from the instrument of FIG. 1;

[0025]FIG. 5 is a broken enlarged transparent side elevation view of theend effector in the fully closed position;

[0026]FIG. 6 is a broken enlarged transparent side elevation view of theend effector in the fully closed position with a male fastener partejected into a female fastener part;

[0027]FIG. 7 is an enlarged side elevation view of a male fastener partaccording to the invention;

[0028]FIG. 8 is an enlarged top view of the fastener part of FIG. 7;

[0029]FIG. 9 is an enlarged side elevation view of a first embodiment ofa female fastener part according to the invention;

[0030]FIG. 10 is am enlarged top view of the fastener part of FIG. 9;

[0031]FIG. 11 is an enlarged schematic view of the distal end of theinstrument of FIG. 1 adjacent the gastroesophageal junction in a firstoperative position;

[0032]FIG. 12 is a view similar to FIG. 11 of the instrument in a secondoperative position;

[0033]FIG. 13 is a view similar to FIG. 11 of the instrument in a thirdoperative position;

[0034]FIG. 14 is a view similar to FIG. 11 of the instrument in a fourthoperative position;

[0035]FIG. 15 is a view similar to FIG. 11 of the instrument in a fifthoperative position;

[0036]FIG. 16 is a side elevation view of one side of a presentlypreferred manual actuator in a first operative position (grasper closedand fastener head open) with the near side of the casing removed;

[0037]FIG. 17 is an isometric view of one side of the actuator of FIG.16 with the near side of the casing removed;

[0038]FIG. 18 is a side elevational view of the other side of theactuator of FIG. 16 with the near side of the casing removed;

[0039]FIG. 19 is an isometric view of the other side of the actuator ofFIG. 16 with the near side of the casing removed;

[0040]FIG. 20 is a view similar to FIG. 16 with the actuator in secondoperative position (grasper open and fastener head open);

[0041]FIG. 21 is a view similar to FIG. 16 with the actuator in themidpoint a third operative position (grasper closed and fastener headpartially closed);

[0042]FIG. 22 is a view similar to FIG. 16 with the actuator in a fourthoperative position (grasper closed and fastener head closed);

[0043]FIG. 23 is a view similar to FIG. 16 with the actuator in a fifthoperative position (grasper closed, fastener head closed, and malefastener part fired);

[0044]FIG. 24 is a view similar to FIG. 21 of the other side of themanual actuator;

[0045]FIG. 25 is a perspective view of a presently preferred embodimentof the end effector in a first operative position;

[0046]FIG. 26 is a perspective view of the presently preferredembodiment of the end effector in a second operative position;

[0047]FIG. 27 is a perspective view of the presently preferredembodiment of the end effector in a third operative position;

[0048]FIG. 28 is a perspective view of the distal end of the presentlypreferred embodiment of the end effector in the third operativeposition;

[0049]FIG. 29 is a perspective view of the proximal end of the presentlypreferred embodiment of the end effector in the third operativeposition;

[0050]FIG. 30 is a perspective view of the major components of thepresently preferred embodiment of the end effector in the thirdoperative position;

[0051]FIG. 31 is a perspective view of the major components of thepresently preferred embodiment of the end effector in a fourth operativeposition;

[0052]FIG. 32 is a perspective view of the stationary component and thegrasper of the presently preferred embodiment of the end effector;

[0053]FIG. 33 is a perspective view of the grasper component and thefastener firing component of the presently preferred embodiment of theend effector;

[0054]FIG. 34 is a view similar to FIG. 33 of the other side of thegrasper component and the fastener firing component;

[0055]FIG. 35 is a perspective view of the top side of a presentlypreferred embodiment of a female fastener part in the female fastenercarrier;

[0056]FIG. 36 is a perspective view of the bottom of the presentlypreferred female fastener part;

[0057]FIG. 37 is a perspective view of the presently preferred femalefastener part coupled to the male fastener part;

[0058]FIG. 38 is a broken, partially cut away perspective view of analternate preferred embodiment showing the firing member receiving amale fastener part;

[0059]FIG. 39 is a view similar to FIG. 38 from a different perspective;

[0060]FIG. 40 is a view similar FIG. 39 showing the firing member raisedand the leaf preventing a male fastener part from moving off the track;

[0061]FIG. 41 is a broken perspective view of the embodiment of FIGS.38-40 showing the end effector with the firing member with a malefastener part engaged therein;

[0062]FIG. 42 is a perspective view of the firing member and malefastener part engaged therein by a leaf spring;

[0063]FIG. 43 is a perspective view of the firing member with the leafspring disengaged from the male fastener part to release the malefastener part;

[0064]FIG. 44 is a perspective view showing the end effector with thefiring member with a male fastener part with the leaf spring disengagedfrom the male fastener part to release the male fastener part;

[0065]FIG. 45 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-44 showing the store of female fastener partswith a female fastener part in position to receive a male fastener part;

[0066]FIG. 46 is a broken perspective view of the embodiment of FIGS.38-45 showing the female fastener part shuttle in position to retrieve afemale fastener part from the store of female fastener parts;

[0067]FIG. 47 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-46 showing the female fastener part shuttle in anintermediate position; and

[0068]FIG. 48 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-47 showing the female fastener part and malefastener parts coupled with the ejector spring engaging the barb of themale fastener part.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] Referring now to FIGS. 1 through 4, a first embodiment of anendoscopic surgical instrument 10 includes a torsionally rigid butflexible tube 12, preferably made from polyethylene, and having aproximal end 14 and a distal end 16, a grasping and fastening endeffector 18 coupled to the distal end 16 of the tube 12, and a manualactuator 20 coupled to the proximal end 14 of the tube 12. The manualactuator 20 is coupled to the end effector 18 by three flexible cables22, 24, 26 which extend through the flexible tube 12. Each of the cablesis preferably formed from an outer coil sheath 22 a, 24 a, 26 a, and aninner pull wire 22 b, 24 b, 26 b. The actuator 20 includes three levers22 c, 24 c, 26 c which are coupled to respective pull wires 22 b, 24 b,26 b. The tube 12 also contains a lumen 28 for receiving a manipulableendoscope 2 and the end effector 18 includes a passage 30 for the distalend 4 of the endoscope 2. Preferably, the overall diameters of theflexible tube 12 and the end effector 18 (when in the position shown inFIG. 2) do not exceed approximately 20 mm (and are preferably no morethan 16 mm) so that the instrument may be delivered transorally throughthe esophagus to the fundus of the stomach.

[0070] The end effector 18 has a substantially cylindrical stationarymember 31, a rotatable fastener head 40, and a grasper 42. Thestationary member 31 has a relatively flexible proximal portion 32 and arelatively rigid distal portion 34. The distal portion is rigid so thata store of male fastener parts and firing member can be located therein.The length of the rigid portion depends on the number of male fastenerparts desired to be stored. The distal portion 34 has a flattened part36 which angles down toward the distal end 38 of the stationary member31. As will be described in more detail below with reference to FIGS. 5and 6, the rotatable fastener head 40 is coupled to the distal end ofthe flattened portion 36 and is rotatable toward and away from theflattened portion 36 as seen best in FIGS. 2 and 3. The rotatablegrasper 42 is coupled to the distal end of the flattened portion 36proximal of the rotatable fastener head 40 and is rotatable toward andaway from the flattened portion 36 as seen best in FIGS. 1 and 2. Therotatable fastener head 40 is coupled to the cable 24 so that itsmovement is controlled by the lever 24 c and the grasper 42 is coupledto the cable 26 so that its movement is controlled by the lever 26 c.

[0071] Referring now to FIGS. 4-6, the stationary member 31 of the endeffector 18 includes a store 44 for male fastener parts, e.g. 46, and asubstantially radial port 48 through which male fastener parts areejected. As will be described in more detail below with reference toFIGS. 7 and 8, the male fasteners have a substantially T-shaped profileand the store 44 is a substantially T-shaped track which is dimensionedto hold approximately six male fastener parts. A biasing spring 50 urgesthe male fasteners distally along the track into position adjacent theport 48. A rotatable firing member 52 is located adjacent to the distalend of the track 44 and is coupled to the cable 22. Thus, operation ofthe lever 22 c (FIG. 1) rotates the rotatable firing member 52 therebyejecting a male fastener part through the port 48. A lower flange 54 onthe member 52 prevents distal movement of the fastener parts in thetrack 44 until the member 52 is rotated back to its original position.

[0072] Referring generally to FIGS. 1-6, the rotatable fastener head 40includes a store 56 for female fastener parts, e.g. 57, and a slidingtray 58 for moving female fastener parts out of the store 56. Thesliding tray 58 is moved automatically by a wire link 60 which causesthe tray to move away from the store 56 when the rotatable fastener head40 is rotated from the open position (FIGS. 1 and 2) to the closedposition (FIGS. 3-6). As will be described in more detail below withreference to FIGS. 9 and 10, according to one embodiment, the femalefastener parts are generally disk shaped and are held in a stack in thestore 56. A spring 62 biases the fastener parts into the tray 58 whenthe rotatable fastener head 40 is in the open position. The tray 58 isdimensioned such that a single fastener part is retrieved from the stackand moved in the tray to a position opposite to the port 48 when therotatable fastener head 40 is rotated from the open position to theclosed position.

[0073] Turning now to FIGS. 7-10, a presently preferred male fastenerpart 46 has a disk shaped base 46 a, a central upstanding shaft 46 b,and tapered barb 46 c at the end of the shaft. According to a preferredembodiment, the base is approximately 0.3 inches in diameter andapproximately 0.040 inches thick, the upstanding member is approximately0.140 inches tall, and the barb is approximately 0.10 inches long. Afirst embodiment of a female fastening member 57 is a substantially flatdisk 57 a, having a central hole 57 b, and four radially outwardextending peripheral tabs 57 c-57 f. Four radial strain relief slits 57g-57 j are preferably provided adjacent to the hole 57 b. The femalefastener is approximately 0.3 inches in diameter and approximately 0.040inches thick. Both the male fastener and the female fastener parts aremade from biocompatible polymers. The barb 46 c, the shaft 46 b, and thehole 57 b are dimensioned such that the barb may be forced through thehole to lock the fastener parts together, but that once locked together,the parts will not easily separate. The peripheral tabs 57 c-57 f aredimensioned such that they hold the female fastener part in the slidingtray prior to being locked together with the male fastener part, butthat they allow the female fastener part to be pulled out of the trayafter it is locked together with the male fastener part. For example,the tabs are thin enough to bend, flex, or shear off when the femalefastener part is pulled out of the tray.

[0074] As mentioned above, the instrument of the invention isadvantageously utilized in a fundoplication procedure. With referencenow to FIGS. 1, 2 and 11-15, the instrument 10 is prepared by insertinga manipulable endoscope 2 into the proximal end of the instrument andthreading the endoscope through the lumen of the flexible tube 12 outthrough the end of the end effector 18. With the grasper 42 closed andthe rotatable fastener head 40 in the first (open) position (as shown inFIGS. 2 and 11, the end effector 18 is inserted into the mouth of thepatient and guided down through the esophagus 3 into the stomach 5 withthe aid of the endoscope 2. When the grasper 42 and the rotatablefastener head 40 are distal of the fundus 7, the grasper 42 is opened asshown in FIG. 12 and the end effector is raised toward the fundus 7 sothat the fundus and the lower end of the esophagus 3 are located betweenthe stationary part 31 of the end effector and the grasper 42. Thegrasper 42 is closed to hold the gastroesophageal junction as shown inFIG. 13. The rotatable fastener head 40 is then rotated to the closedposition, raising it up toward the fundus 7 and lifting the fundus 7 upagainst the esophagus 3 as shown in FIG. 14. With the instrument in thisconfiguration, the rotatable firing member (52 in FIGS. 5 and 6) isactuated and a male fastener member 46 is ejected out of the radial port48, through the esophagus 3 and the fundus 7, and into a female fastenermember 57 as shown in FIG. 15. The rotatable firing member is thenreturned to its original position, moving the flange 54 away from themale fastener store 44 and allowing a second male fastener to be pushedonto the second rotatable member 52. The rotatable fastener head 40 ismoved to the open position, releasing the female fastener, and returningthe tray to the store of female fasteners to receive a second femalefastener. The grasper 42 is opened and the instrument may then berepositioned and the above procedure repeated until the desiredfundoplication is achieved.

[0075]FIGS. 16 through 24 show a presently preferred manual actuator100, according to the invention, which is provided with a lock-outfeature to prevent the inadvertent firing of a male fastener memberbefore the rotatable fastener head is in the proper position and with alockable lever for holding the grasper in the closed position. Referringnow to FIGS. 16-20, and as seen best in FIGS. 17 and 19, the actuator100 has a generally pistol-shaped housing 101 which is formed from twomating halves 102, 104. By generally pistol-shaped, it is meant that thehousing has a grip portion 108 and a barrel portion 109. Three levers(106, 118, 136) and a toothed cam (122) are rotatably mounted within thehousing.

[0076] The first lever 106 is mounted adjacent to the gripping portion108 of the housing and is pivotally coupled at its upper end to thehousing by a pin 110. A slotted throughbore 112 in the lever 106 islocated below the pin 110. The slotted throughbore 112 receives theproximal end of cable 26 (which controls the grasper) and the cable isattached to the lever 106 by a crosspin 114. The lower end of the lever106 is provided with a spring biased latch 116 which is operativelyengageable with a notch (not shown) in the housing.

[0077] The second lever 118 is pivotally coupled at one end 120 to theproximal end of the toothed cam 122. The second lever 118 is alsoprovided with a slotted throughbore 124 which receives the proximal endof cable 22 (which controls the fastener firing member). The proximalend of the cable 22 is coupled to the lever 118 by a crosspin 126 in theslotted throughbore 124. The slotted throughbore 124 is located in aportion 118 a of the lever 118 which is broader than an immediatelyadjacent portion 118 b. A locking stop 113 is provided in housing half104 (FIG. 18) which blocks movement of the broad portion 118 a of thelever as described in more detail below.

[0078] The toothed cam 122 is rotatably coupled to one portion 102 ofthe housing by a pin 128 which is located between the grip portion 108and the barrel portion 109 of the housing. This portion of the housingis provided with a slotted wall 111 (FIG. 16) through which the firstand second levers 106, 118 exit the housing. The slot in the wall 111 isdimensioned to allow passage of the portion 118 b of the lever 118 andmay be dimensioned to prevent the passage of the broader portion 118 a.The cam 122 has a distal curved slotted throughbore 130 which receivesthe proximal end of cable 24 (which controls the rotatable fastenerhead). The proximal end of cable 24 is coupled to the cam 122 by acrosspin 132 which rides in the curved throughbore 130. The cam 122 isprovided with a plurality of peripheral teeth 134 which extend along acurved path from the proximal end of the cam where the lever 118 iscoupled to it, to a point adjacent to the curved throughbore.

[0079] The third lever 136 is rotatably mounted above the cam 122 by apin 138 and is provided with a plurality of radial teeth 140 whichengage the teeth 134 of the cam 122.

[0080] The housing 101 is also provided with a plurality of cable guides142 (FIG. 17) in the barrel portion 109 of the housing half 102 and anendoscope receiving tube 144 (FIG. 18) in the barrel portion 109 of thehousing half 104. In addition, the housing halves 102, 104 are providedwith longitudinal guide slots 146, 148 which engage the crosspin 132 andguide its motion in a longitudinal direction.

[0081] The operation of the actuator 100 is described in sequence withreference to FIGS. 16-24 and with reference to the presently preferredend effector configuration of FIGS. 25-31 which are discussed in moredetail below. FIGS. 16-19 show the positions of the levers 106 and 136when the grasper is closed and the fastener head is opened (see alsoFIG. 25). In this position of lever 136, the lever 118 is positioned sothat it is impossible to move the lever 118 to fire a male fastener. Inparticular, the distal location of lever 136 has caused the radial teeth140 to rotate the cam 122 proximally which has moved the pivot point 120of the lever 118 to a position proximal of its broad portion 118 a. Inorder to move the lever 118, the broad portion 118 a needs to pass thestop 113 (FIG. 18) which prevents its movement. In addition, since thelever 118 must rotate about the pivot point 120, the portion 118 a needsto exit the slot 111 in the housing. However, as described above, theslot may be dimensioned to prevent this movement. With the levers in thepositions shown in FIGS. 16-19, the instrument is in the properorientation for delivery through the esophagus. It will also beappreciated that the positions and locations of the levers are easy tounderstand and provide intuitive indication of the positions of theparts of the end effector. For example, the lever 106 is “closed”relative to the grip 108 indicating that the grasper is closed. Thelever 136 is approximately 180° forward indicating that the fastenerhead is rotated forward (distally) approximately 180°. The lever 118,which is most like the trigger portion of the pistol shaped actuator israised up and out of the way where it cannot be pulled.

[0082] After the end effector is in place at the surgical site, thegrasper is opened (to the position shown in FIG. 26) by releasing thelatch 116 and moving the lever 106 distally as shown in FIG. 20; therebymoving cable 26 which is attached to the grasper 206. After the grasperhas been properly positioned, the lever 106 is moved back and the latch116 holds the grasper locked closed (in the position shown in FIG. 25).

[0083] The rotatable fastener head is now closed (to the position shownin FIGS. 27-30) by rotating the lever 136 proximally which is shown intwo stages in FIGS. 21 and 22. As seen in comparing FIGS. 20, 21, and22, as the lever 136 is rotated proximally, the teeth 140 on the lever136 engage the teeth 134 on the cam 122 causing the cam 122 to rotatedistally. This action causes the curved slot 130 to rotate in a mannerwhich forces the cross pin 132 to move distally in the slots 146, 148.Movement of the crosspin 132 moves the cable 24 distally causing thefastener head to close. At the same time, the pivot point 120 of thelever 118 is rotated above the broad portion 118 a of the lever 118.This moves the broad portion 118 a above the stop 113 and places thelever 118 in a position where the broad portion 118 a does not need toexit the slot 111 and can freely pass alongside the stop 113. As shownin FIG. 22, the lever 118 is now operable to fire a male fastener. Itwill be appreciated that, until the fastening head is completely closed,movement of the firing lever 118 to pull the cable 22 is prevented bythe stop 113. In addition, it will be appreciated that the crosspincoupling 126 remains stationary as the cam 122 causes the lever 118 tobe rotated about this pin.

[0084]FIG. 23 shows the lever 118 moved to the proximal position whichpulls the cable 22 proximally and fires the male fastener part (as shownin FIG. 31). As seen best in FIG. 24, when the firing lever is in theproximal position, the stop 113 is located below the broad portion 118a. It will be appreciated that this position of the lever 118 willprevent the lever 136 from being moved distally. Distal movement of thelever 136 will attempt to rotate the cam 122 in a manner which will movethe lever 118 in a direction where its broad portion 118 a must pass thestop 113. Therefore, before the lever 136 can be moved to open thefastener head, the firing lever 118 must be moved back to the positionshown in FIG. 22. As show in FIGS. 23 and 24, the lever 118 ispreferably concave along its proximal side so that it can be moved overthe lever 106.

[0085] Turning now to FIGS. 25-37, the presently preferred end effectorand fasteners are similar to those described above with reference toFIGS. 1-10 with some differences which will become apparent from thefollowing description.

[0086] The end effector 200 has a substantially cylindrical stationarymember 202, a rotatable fastener head 204, and a grasper 206. Thestationary member 202 has a relatively flexible proximal portion 208 anda relatively rigid distal portion 210. The distal portion 210 has aflattened part 212 which angles down toward the distal end 214 of thestationary member 202. The flattened part 212 is provided with a firstgrasping surface 216 and the grasper 206 is provided with a secondgrasping surface 218. A male fastener exit port 220 is locatedintermediate of the flattened part 212 and the proximal portion 208. Asseen best in FIGS. 30 and 31, a firing member 222 with a movable malefastener part holder 224 is located inside the stationary member 202. Asseen best in FIG. 29, a store 226 of male fastener parts 227 is locatedinside the stationary member 202, proximal of the firing member 222.Individual male fastener parts 227 a are biased from the store into themale fastener part holder 224 by a spring 229 as shown in FIG. 30.According to this embodiment, up to six male fastener parts are held inthe store. As seen best in FIGS. 28 and 29, an endoscope port 228 isprovided in the stationary member 222 below the male fastener part store226. Three cable ports 230, 232, 234 are provided in the stationarymember 202 as shown in FIG. 29 for attaching control cables to thegrasper 206, the fastener head 204, and the firing member 222,respectively.

[0087] The rotatable fastener head 204 includes a store 236 of femalefastener parts 237 and a movable tray 238 for moving female fastenerparts out of the store and into position to receive a male fastener partas described below. According to this embodiment, up to six femalefastener parts are held in the store. The movable tray 238 is coupled tothe fastener head 204 by flanges 238 a, 238 b which slideably engagegrooves 204 a, 204 b in the fastener head as seen best in FIGS. 27-30.The movable fastener head 204 is coupled to the distal end 214 of thestationary member 202 by a pivot axle 240, and a hinged link 242 (FIG.28) couples the fastener head 204 to a control cable (not shown). Whenthe link 242 is moved distally, the fastener head 204 is moved to theclosed position as shown in FIG. 28. When in this position, the hinge242 a in the link 242 is moved past the center of the pivot axle 240which locks the fastener head in the closed position. The sliding tray238 is coupled via a flange 238 c and a pivoting link 244 to the pivotaxle 240 as seen best in FIGS. 25 and 26. This link 244 causes the tray238 to slide from the position shown in FIGS. 25 and 26 to the positionshown in FIGS. 27 and 28 when the fastener head 204 is closed.

[0088] The firing member 222 is coupled to the stationary member 202 bythe same pivot axle 240 as the fastener head as shown in FIGS. 25, 26,30, 33, and 34. The firing member 222 is coupled to a control cable (notshown) by a lower flange 222 a as shown in FIGS. 30, 33, and 34. Asshown in FIG. 32, the distal portion 210 of the stationary member 202 isprovided with a stepped port 234 through which the control cable for thefiring member passes and which holds the cable sheath. When the controlcable pulls the flange 222 a proximally, the firing member 222 is movedtowards the exit port 220. The movable male fastener part holder 224 isprovided with a proximal flange 224 a which is coupled to a lateralportion 210 a of the stationary member 202 by a pivoting link 246 asseen best in FIG. 30. This link 246 causes the holder 224 to slidedistally as shown in FIG. 31 when a male fastener part is fired. Thepurpose of the holder 224 is to prevent the male fastener part fromfalling out through the port 220 when the fastener head is open and toallow the firing operation to be aborted while retaining the malefastener part.

[0089] As seen best in FIGS. 33 and 34, the grasper 206 is pivotallycoupled to the distal end of the firing member 222 on a pivot axle 250.The grasper 206 is also coupled to a control cable (not shown) via ahole 252 located above its pivot connection. As shown in FIGS. 31 and32, the distal portion 210 of the stationary member 202 is provided witha stepped port 230 through which the control cable for the grasperpasses and which holds the cable sheath. When the control cable ispulled proximally, the grasper is moved to the closed position shown inFIG. 25.

[0090] Turning now to FIGS. 35-37, the presently preferred male fastenerpart 227 (substantially the same as the fastener part 46 describedabove) has a disk shaped base 227 a, a central upstanding shaft 227 b,and tapered barb 227 c at the end of the shaft. The presently preferredfemale fastening member 237 is a substantially flat rectangular member237 a defining a central hole 237 b. The hole 237 b has a tapered entry237 c and four radial strain relief slots 237 d. Four flexible orfrangible peripheral tabs 237 e are provided on the periphery of therectangular member. These tabs hold the fastener part in the tray 238 asshown in FIG. 35, but allow it to be pulled out of the tray after it iscoupled to a male fastener part as shown in FIG. 37.

[0091] Turning now to FIGS. 38-48, an alternate preferred end effector300 is similar to the end effector 200 described above, with similarreference numerals referring to similar parts.

[0092] The end effector 300 has a substantially cylindrical stationarymember 302, a rotatable fastener head 304, and a grasper 306. Thestationary member 302 has a flattened part 312 which angles down towardthe distal end 314 of the stationary member 302. The flattened part 312is provided with a first grasping surface 316 and the grasper 306 isprovided with a second grasping surface 318. A male fastener exit port320 is located at the proximal end of the flattened part 312. As seenbest in FIGS. 38-44, a firing member 322 with a male fastener partholder 324 is located inside the stationary member 302.

[0093] As seen best in FIGS. 41-44, the holder 324 has a pair of flangedspringy arms 324 a, 324 b which hold the base of a male fastener part,e.g. 327 a. The arms 324 a, 324 b are biased outward to the positionshown in FIG. 43. As seen best in FIGS. 41 and 44, the interior of thestationary member 302 has contoured walls 303 a, 303 b which hold thearms 324 a, 2324 b close together, securing the male fastener part. Whenthe firing member 322 is raised into the firing position, as shown inFIGS. 40 and 44, the springy arms 324 a, 324 b move outward as shown inFIG. 43, thereby releasing the male fastener part.

[0094] As seen best in FIGS. 38-40, a store 326 of male fastener parts327 a, 327 b, etc. is located inside the stationary member 302, proximalof the firing member 322. Individual male fastener parts 327 a, 327 b,etc. are biased from the store into the male fastener part holder 324 bya spring (not shown). According to this embodiment, a leaf spring 325having an upstanding flange 325 a and a distal tongue 325 b (FIG. 40) isarranged beneath the row of male fastener parts in the store 326. Asshown in FIG. 40, the distal most fastener part is prevented fromexiting the store 326 by the flange 325 a when the firing member 322 isin the firing position. When the firing member 322 returns from thefiring position as seen in FIGS. 38 and 39, the tongue 325 b of the leafspring is depressed by the firing member 322 and the flange 325 a isthereby moved away from the next fastener part allowing it to enter theholder 324 of the firing member 322.

[0095] As seen best in FIGS. 41, 44, and 48, an endoscope port 328 isprovided in the stationary member 322 below the male fastener part store326. Three cable ports 330, 332, 334 are provided in the stationarymember 302 as shown in FIGS. 41 and 44 for attaching control cables tothe grasper 306, the fastener head 304, and the firing member 322,respectively.

[0096] As shown in FIGS. 41-48, the rotatable fastener head 304 includesa store 236 of female fastener parts 337 and a movable tray 338 formoving female fastener parts out of the store and into position toreceive a male fastener part as described below. According to thisembodiment, up to six female fastener parts are held in the store. Asseen best in FIG. 44, the movable tray 338 is coupled to the fastenerhead 304 by flanges 338 a, 338 b which slideably engage flanges 304 a,304 b in the fastener head. The sliding tray 338 is coupled via a flange338 c and a pivoting link 344 to the pivot axle 340 as seen best inFIGS. 44, 45, and 48. This link 344 causes the tray 338 to slide fromthe position shown in FIG. 44 to the position shown in FIGS. 45 and 48when the fastener head 304 is closed.

[0097] As seen best in FIGS. 45-48, the female fastener parts 337 a-337e are biased out of the store 336 by a bifurcated leaf spring 305 andare held laterally in line by a support post 307 which is seen best inFIG. 46 where the movable tray has been removed to better expose thespring 305 and the post 307. A fastener discharge spring 309 is locatedadjacent to the female fastener store 336 and is provided with a malefastener engaging surface 311. As the fastener head 304 is moved fromthe open position shown in FIG. 46 to the closed position shown in FIG.45, the movable tray 338 moves the top most female fastener part 337 aout of the store and over the discharge spring 309. FIG. 47 shows thetray 338 in a midway position as the fastener 337 a is being moved intoposition to receive a male fastener part. When a male fastener is firedinto the female fastener as shown in FIG. 48, The end of the malefastener will engage the surface 311 on the spring 309 and compress thespring. It will be appreciated that as the firing member 322 is returnedfrom the firing position, the spring 309 will push against the end ofthe male fastener thereby pushing the female fastener out of the tray,bending or breaking the tabs of the female fastener.

[0098] The firing member 322 is coupled to the stationary member 302 bythe same pivot axle 340 as the fastener head as shown in FIGS. 39, 40,42, 43 and 48. The firing member 322 is coupled to a control cable (notshown) by a lower flange 322 a as shown in FIG. 48. When the controlcable pulls the flange 322 a proximally, the firing member 322 is movedtowards the exit port 320.

[0099] There have been described and illustrated herein severalembodiments of a flexible endoscopic surgical instrument forinvagination and fundoplication. While particular embodiments of theinvention have been described, it is not intended that the invention belimited thereto, as it is intended that the invention be as broad inscope as the art will allow and that the specification be read likewise.It will therefore be appreciated by those skilled in the art that yetother modifications could be made to the provided invention withoutdeviating from its spirit and scope as so claimed.

1. An endoscopic surgical instrument for deploying a two part fastenerhaving a male fastener part and a female fastener part, comprising: a) aflexible tube having a proximal end and a distal end; b) at least onecontrol cable having a proximal end and a distal end and extendingthrough said tube; c) an end effector coupled to said distal end of saidtube, said end effector including means for holding the male fastenerpart and the female fastener part in opposed relation; d) movablefastening means coupled to said distal end of said at least one controlcable for moving one of the male fastener part and the female fastenerpart into locking relation with the other of the male fastener part andthe female fastener part; and e) actuation means coupled to saidproximal end of said tube and said proximal end of said at least onecable for moving said movable fastening means.
 2. An endoscopic surgicalinstrument according to claim 1, further comprising: f) a male fastenerpart held by said means for holding; and g) a female fastener part heldby said means for holding, said female fastener part having a deformableor frangible portion which allows said female fastener part to bereleased from said means for holding.
 3. An endoscopic surgicalinstrument according to claim 2, wherein: said deformable or frangibleportion includes a plurality of peripheral tabs.
 4. An endoscopicsurgical instrument according to claim 2, wherein: said female fastenerpart is a circular disk with a central opening, and said male fastenerpart is a circular disk with a barbed upstanding portion, said barbedupstanding portion dimensioned to enter said central opening.
 5. Anendoscopic surgical instrument according to claim 2, wherein: saidfemale fastener part is a substantially rectangular member with acentral opening, and said male fastener part is a circular disk with abarbed upstanding portion, said barbed upstanding portion dimensioned toenter said central opening.
 6. An endoscopic surgical instrumentaccording to claim 2, wherein: said female fastener part is asubstantially rectangular member with a central opening, and said malefastener part is a substantially rectangular member with a barbedupstanding portion, said barbed upstanding portion dimensioned to entersaid central opening.
 7. An endoscopic surgical instrument according toclaim 1, wherein: said flexible tube includes a port for an endoscope.8. An endoscopic surgical instrument according to claim 7, wherein: saidend effector includes an exit port for the endoscope.
 9. An endoscopicsurgical instrument according to claim 1, wherein: said end effector hasa relatively flexible portion and a relatively non-flexible portion. 10.An endoscopic surgical instrument according to claim 9, wherein: saidnon-flexible portion has a tapered first grasping surface.
 11. Anendoscopic surgical instrument according to claim 10, wherein: said endeffector includes a rotatable grasper having a second grasping surface.12. An endoscopic surgical instrument according to claim 1, wherein:said end effector includes means for storing a plurality of malefastener parts, one behind the other.
 13. An endoscopic surgicalinstrument according to claim 12, wherein: said end effector includesmeans for storing a plurality of female fastener parts, one on top ofthe other.
 14. An endoscopic surgical instrument according to claim 13,wherein: said means for storing a plurality of female fastener partsincludes a rotatable fastener head.
 15. An endoscopic surgicalinstrument according to claim 14, wherein: said rotatable fastener headincludes shuttle means for moving one of the plurality of femalefastener parts away from the plurality of female fastener parts.
 16. Anendoscopic surgical instrument according to claim 15, wherein: saidrotatable fastener head includes an ejection spring and said shuttlesmeans is for moving one of the plurality of female fastener parts awayfrom the plurality of female fastener parts and over said ejectionspring.
 17. An endoscopic surgical instrument according to claim 12,wherein: said means for storing includes biasing means for biasing themale fastener parts towards said movable fastening means.
 18. Anendoscopic surgical instrument according to claim 17, wherein: saidmovable fastening means includes blocking means for blocking biasedmovement of the male fastener parts when said movable fastening meansmoves a male fastener part into locking relation with a female fastenerpart.
 19. An endoscopic surgical instrument according to claim 17,wherein: said means for storing includes releasable means for blockingbiased movement of the male fastener parts when said movable fasteningmeans moves a male fastener part into locking relation with a femalefastener part.
 20. An endoscopic surgical instrument according to claim19, wherein: said movable fastening means engages said releasable meansfor blocking.
 21. An endoscopic surgical instrument according to claim1, further comprising: f) grasping means for grasping tissue and holdingtissue relative to said movable fastening means.
 22. An endoscopicsurgical instrument according to claim 21, wherein: said at least onecontrol cable includes a first control cable coupled to said movablefastening means and a second control cable coupled to said graspingmeans.
 23. An endoscopic surgical instrument according to claim 22,wherein: said actuation means includes fastener actuation means coupledto said first cable and grasper actuation means coupled to said secondcable.
 24. An endoscopic surgical instrument according to claim 17,wherein: said movable fastening means includes movable means for holdingand releasing a male fastener part.
 25. An endoscopic surgicalinstrument according to claim 24, wherein: said movable means forholding and releasing includes a sliding member.
 26. An endoscopicsurgical instrument according to claim 24, wherein: said movable meansfor holding and releasing includes a springy arm.
 27. An endoscopicsurgical instrument according to claim 26, wherein: said movable meansfor holding and releasing includes a pair of springy arms.
 28. Asurgical instrument for deploying a two part fastener having a malefastener part and a female fastener part, comprising: a) a tube having aproximal end and a distal end; b) at least one control member having aproximal end and a distal end and extending through said tube; c) an endeffector coupled to said distal end of said tube, said end effectorincluding i) a stationary part having a proximal end and a distal end,and means for holding one of the male and female fastener parts, ii) afirst rotatable member rotatably coupled to said distal end of saidstationary part and having means for holding the other of the male andfemale fastener parts, said first rotatable member being coupled to saiddistal end of said at least one control member; and d) actuation meanscoupled to said proximal end of said tube and said proximal end of saidat least one control member for rotating said first rotatable memberfrom a first open position to a second closed position where said firstrotatable member extends substantially proximally from said distal endof said stationary member.
 29. A surgical instrument according to claim28, wherein: said first rotatable member extends distally away from saidstationary member when in said first open position.
 30. A surgicalinstrument according to claim 28, wherein: said first rotatable memberrotates more than 90° from said open position to said closed position.31. A surgical instrument according to claim 28, further comprising: e)a second control member having a proximal end and a distal end andextending through said tube, wherein said end effector includes firingmeans for pushing the male fastener part into the female fastener partwhen said first rotatable member is in said closed position, said firingmeans being coupled to said distal end of said second control member,said actuation means being coupled to said proximal end of said secondcontrol member for activating said firing means.
 32. A surgicalinstrument according to claim 28, further comprising: e) a male fastenerpart held by one of said means for holding; and f) a female fastenerpart held by the other of said means for holding, said female fastenerpart having a deformable or frangible portion which allows said femalefastener part to be released from said means for holding.
 33. A surgicalinstrument according to claim 32, wherein: said deformable or frangibleportion includes a plurality of peripheral tabs.
 34. A surgicalinstrument according to claim 32, wherein: said female fastener part isa circular disk with a central opening, and said male fastener part is acircular disk with a barbed upstanding portion, said barbed upstandingportion dimensioned to enter said central opening.
 35. A surgicalinstrument according to claim 32, wherein: said female fastener part isa substantially rectangular member with a central opening, and said malefastener part is a circular disk with a barbed upstanding portion, saidbarbed upstanding portion dimensioned to enter said central opening. 36.A surgical instrument according to claim 32, wherein: said femalefastener part is a substantially rectangular member with a centralopening, and said male fastener part is a substantially rectangularmember with a barbed upstanding portion, said barbed upstanding portiondimensioned to enter said central opening.
 37. A surgical instrumentaccording to claim 28, wherein: said tube includes a port for anendoscope.
 38. A surgical instrument according to claim 37, wherein:said end effector includes an exit port for the endoscope.
 39. Asurgical instrument according to claim 28, wherein: said end effectorhas a relatively flexible portion and a relatively non-flexible portion.40. A surgical instrument according to claim 39, wherein: saidnon-flexible portion has a tapered first grasping surface.
 41. Asurgical instrument according to claim 40, wherein: said end effectorincludes a rotatable grasper having a second grasping surface.
 42. Asurgical instrument according to claim 31, wherein: said end effectorincludes means for storing a plurality of male fastener parts, onebehind the other.
 43. A surgical instrument according to claim 42,wherein: said end effector includes means for storing a plurality offemale fastener parts, one on top of the other.
 44. A surgicalinstrument according to claim 43, wherein: said means for storing aplurality of female fastener parts is located in said first rotatablemember.
 45. A surgical instrument according to claim 44, wherein: saidfirst rotatable member includes shuttle means for moving one of theplurality of female fastener parts away from the plurality of femalefastener parts.
 46. A surgical instrument according to claim 45,wherein: said first rotatable member includes an ejection spring andsaid shuttles means is for moving one of the plurality of femalefastener parts away from the plurality of female fastener parts and oversaid ejection spring.
 47. A surgical instrument according to claim 43,wherein: said means for storing includes biasing means for biasing themale fastener parts toward said firing means.
 48. A surgical instrumentaccording to claim 47, wherein: said firing means includes blockingmeans for blocking biased movement of the male fastener parts when saidfiring means moves a male fastener part into locking relation with afemale fastener part.
 49. A surgical instrument according to claim 47,wherein: said means for storing includes releasable means for blockingbiased movement of the male fastener parts when said firing means movesa male fastener part into locking relation with a female fastener part.50. A surgical instrument according to claim 49, wherein: said firingmeans engages said releasable mea ns for blocking.
 51. A surgicalinstrument according to claim 28, further comprising: e) grasping meansfor grasping tissue and holding tissue relative to said stationary partand said first rotatable member.
 52. A surgical instrument according toclaim 51, wherein: said at least one control member includes a firstcontrol member coupled to said first rotatable member and a secondcontrol member coupled to said grasping means.
 53. A surgical instrumentaccording to claim 52, wherein: said actuation means includes fasteneractuation means coupled to said first control member and grasperactuation means coupled to said second control member.
 54. A surgicalinstrument according to claim 47, wherein: said firing means includesmovable means for holding and releasing a male fastener part.
 55. Asurgical instrument according to claim 54, wherein: said movable meansfor holding and releasing includes a sliding member.
 56. A surgicalinstrument according to claim 54, wherein: said movable means forholding and releasing includes a springy arm.
 57. An endoscopic surgicalinstrument according to claim 56, wherein: said movable means forholding and releasing includes a pair of springy arms.
 58. A surgicalinstrument, comprising: a) a tube having a proximal end and a distalend; b) at least one control member having a proximal end and a distalend and extending through said tube; c) an end effector coupled to saiddistal end of said tube, said end effector including i) a stationarypart having a proximal end and a distal end, ii) a first rotatablemember rotatably coupled to said distal end of said stationary part,said first rotatable member being coupled to said distal end of said atleast one control member, one of said stationary part and said firstrotatable member having means for carrying a deployable fastener, andiii) a gripping means coupled to said at least one control member; andd) actuation means coupled to said proximal end of said tube and saidproximal end of said at least one control member for rotating said firstrotatable member from a first open position to a second closed positionand for opening and closing said gripping means.
 59. A surgicalinstrument according to claim 58, wherein: said gripping means islocated between said stationary part and said first rotatable member.60. A surgical instrument according to claim 58, wherein: where saidfirst rotatable member extends distally away from said stationary memberwhen in said first open position, and where said first rotatable memberextends substantially proximally from said distal end of said stationarymember when in said second closed position.
 61. A surgical instrumentaccording to claim 58, wherein: said at least one control memberincludes a first control member coupled to said first rotatable memberand a second control member coupled to said gripping means.
 62. Asurgical instrument according to claim 61, wherein: said gripping meansincludes a second rotatable member coupled to said stationary part. 63.A surgical instrument according to claim 62, wherein: said secondrotatable member has a first gripping surface and said stationary parthas a second gripping surface.
 64. A surgical instrument according toclaim 63, wherein: said second gripping surface is tapered.
 65. Asurgical instrument according to claim 58, wherein: said first rotatablemember and said second rotatable member rotate about the same axis. 66.A surgical instrument according to claim 58, wherein: said firstrotatable member and said second rotatable member rotate about differentaxes.
 67. A surgical instrument according to claim 61, wherein: saidfirst control member is coupled to said first rotatable member by ahinged link.
 68. A surgical instrument according to claim 58, wherein:said tube includes a port for an endoscope.
 69. A surgical instrumentaccording to claim 68, wherein: said end effector includes an exit portfor the endoscope.
 70. A surgical instrument, comprising: a) a tubehaving a proximal end and a distal end; b) at least one control memberhaving a proximal end and a distal end and extending through said tube;c) an end effector coupled to said distal end of said tube, said endeffector including means for holding a deployable fastener having asharp end and means for ejecting the deployable fastener, said means forejecting being coupled to said distal end of said at least one controlmember; d) a first rotatable member coupled to said distal end of saidend effector and coupled to said at least one control cable, said firstrotatable member having means for receiving the sharp end of thedeployable fastener; and e) actuation means coupled to said proximal endof said tube and said proximal end of said at least one control memberfor moving said first rotatable member from a first open position inwhich said first rotatable member extends away from said end effector toa second closed position in which said means for receiving is alignedwith said means for ejecting, said actuation means also for actuatingsaid means for ejecting and including lock-out means for preventingactuation of said means for ejecting when said first rotatable member isnot in said second closed position.
 71. A surgical instrument accordingto claim 70, wherein: said at least one control member includes a firstcontrol member coupled to said means for ejecting and a second controlmember coupled to said first rotatable member.
 72. A surgical instrumentaccording to claim 71, wherein: said actuation means includes firstactuation means coupled to said first control member and secondactuation means coupled to said second control member.
 73. A surgicalinstrument according to claim 70, wherein: said lock-out means includesa raised stop.
 74. A surgical instrument according to claim 70, wherein:said lock-out means also prevents said first rotatable member from beingopened until said means for ejecting is deactuated.
 75. A surgicalinstrument according to claim 70, wherein: said actuation means includesa first lever for rotating said first rotatable member and a secondlever for actuating said means for ejecting.
 76. A surgical instrumentaccording to claim 75, wherein: said first lever indicates the positionof said first rotatable member.
 77. A surgical instrument according toclaim 75, wherein: said first lever and said second lever are coupled toeach other by engaging teeth.
 78. A surgical instrument according toclaim 77, wherein: said actuation means further includes a rotatableradially toothed member, said second lever is pivotally coupled to saidrotatable radially toothed member, and said first lever has a pluralityof radial teeth which engage said rotatable radially toothed member. 79.A surgical instrument according to claim 78, wherein: said secondcontrol member is coupled to said rotatable radially toothed member. 80.A surgical instrument according to claim 79, wherein: said rotatableradially toothed member has a curved slot, said actuation means furtherincludes a cross pin residing in said curved slot, and said secondcontrol member is coupled to said crosspin.
 81. A surgical instrumentaccording to claim 70, further comprising: f) a rotatable graspercoupled to said end effector; and said actuation means further includingmeans for rotating said rotatable grasper.
 82. An endoscopic surgicalinstrument, comprising: a) a flexible tube having a proximal end and adistal end; b) at least one control cable having a proximal end and adistal end and extending through said tube; c) an end effector coupledto said distal end of said tube, said end effector including i) astationary part having a proximal end and a distal end, and means forholding one of a male and female fastener part, ii) a first rotatablemember rotatably coupled to said distal end of said stationary part andhaving means for holding the other of a male and female fastener part,said first rotatable member being coupled to said distal end of said atleast one control member, iii) a gripping means coupled to said at leastone control member, and iv) movable fastening means coupled to saiddistal end of said at least one control cable for moving one of saidmale fastener part and said female fastener part into locking relationwith the other of said male fastener part and said female fastener part;and d) actuation means coupled to said proximal end of said tube andsaid proximal end of said at least one control member for i) opening andclosing said gripping means, ii) rotating said first rotatable memberfrom a first open position to a second closed position, and iii)actuating said movable fastening means, wherein said actuating meansincludes lock-out means for preventing actuation of said movablefastening means when said first rotatable member is not in said secondclosed position.
 83. An endoscopic surgical instrument according toclaim 82, wherein: said gripping means is located between saidstationary part and said first rotatable member.
 84. An endoscopicsurgical instrument according to claim 82, wherein: said first rotatablemember extends distally away from said stationary member when in saidfirst open position, and said first rotatable member extendssubstantially proximally from said distal end of said stationary memberwhen in said second closed position.
 85. An endoscopic surgicalinstrument according to claim 82, further comprising: e) a male fastenerpart held by one of said means for holding; and f) a female fastenerpart held by the other of said means for holding, said female fastenerpart having a deformable or frangible portion which allows said femalefastener part to be released from said means for holding.
 86. Anendoscopic surgical instrument according to claim 85, wherein: saiddeformable or frangible portion includes a plurality of peripheral tabs.87. An endoscopic surgical instrument according to claim 85, wherein:said female fastener part is a circular disk with a central opening, andsaid male fastener part is a circular disk with a barbed upstandingportion, said barbed upstanding portion dimensioned to enter saidcentral opening.
 88. An endoscopic surgical instrument according toclaim 85, wherein: said female fastener part is a substantiallyrectangular member with a central opening, and said male fastener partis a circular disk with a barbed upstanding portion, said barbedupstanding portion dimensioned to enter said central opening.
 89. Anendoscopic surgical instrument according to claim 85, wherein: saidfemale fastener part is a substantially rectangular member with acentral opening, and said male fastener part is a substantiallyrectangular member with a barbed upstanding portion, said barbedupstanding portion dimensioned to enter said central opening.
 90. Anendoscopic surgical instrument according to claim 82, wherein: saidflexible tube includes a port for an endoscope.
 91. An endoscopicsurgical instrument according to claim 90, wherein: said end effectorincludes an exit port for the endoscope.
 92. An endoscopic surgicalinstrument according to claim 82, wherein: said end effector has arelatively flexible portion and a relatively non-flexible portion. 93.An endoscopic surgical instrument according to claim 92, wherein: saidnon-flexible portion has a tapered first grasping surface.
 94. Anendoscopic surgical instrument according to claim 93, wherein: saidgrasping means has a second grasping surface.
 95. An endoscopic surgicalinstrument according to claim 82, wherein: said end effector includesmeans for storing a plurality of male fastener parts, one behind theother.
 96. An endoscopic surgical instrument according to claim 95,wherein: said end effector includes means for storing a plurality offemale fastener parts, one on top of the other.
 97. An endoscopicsurgical instrument according to claim 96, wherein: said means forstoring a plurality of female fastener parts is located in said firstrotatable member.
 98. An endoscopic surgical instrument according toclaim 97, wherein: said first rotatable member includes shuttle meansfor moving one of the plurality of female fastener parts away from theplurality of female fastener parts.
 99. An endoscopic surgicalinstrument according to claim 98, wherein: said first rotatable memberincludes an ejection spring and said shuttles means is for moving one ofthe plurality of female fastener parts away from the plurality of femalefastener parts and over said ejection spring.
 100. An endoscopicsurgical instrument according to claim 95, wherein: said means forstoring includes biasing means for biasing the male fastener partstowards said movable fastening means.
 101. An endoscopic surgicalinstrument according to claim 100, wherein: said movable fastening meansincludes blocking means for blocking biased movement of the malefastener parts when said movable fastening means moves a male fastenerpart into locking relation with a female fastener part.
 102. Anendoscopic surgical instrument according to claim 100, wherein: saidmeans for storing includes releasable means for blocking biased movementof the male fastener parts when said movable fastening means moves amale fastener part into locking relation with a female fastener part.103. An endoscopic surgical instrument according to claim 102, wherein:said movable fastening means engages said releasable means for blocking.104. An endoscopic surgical instrument according to claim 100, wherein:said movable fastening means includes movable means for holding andreleasing a male fastener part.
 105. An endoscopic surgical instrumentaccording to claim 104, wherein: said movable means for holding andreleasing includes a sliding member.
 106. An endoscopic surgicalinstrument according to claim 104, wherein: said movable means forholding and releasing includes a springy arm.
 107. An endoscopicsurgical instrument according to claim 106, wherein: said movable meansfor holding and releasing includes a pair of springy arms.
 108. A methodof performing invagination and fundoplication, comprising: a) insertinga grasping and fastening instrument through the mouth and throat intothe stomach; b) grasping the fundus of the esophagus with theinstrument; c) invaginating the fundus with the instrument; d) applyinga two part fastener with the instrument to plicate the fundus.
 109. Amethod of performing invagination and fundoplication, comprising: a)inserting a fasting instrument through the mouth and throat into thestomach; b) grasping the fundus of the esophagus; c) invaginating thefundus; d) applying a two part fastener with the instrument to plicatethe fundus.